|Publication number||US7967847 B2|
|Application number||US 11/491,724|
|Publication date||Jun 28, 2011|
|Filing date||Jul 24, 2006|
|Priority date||Jul 24, 2006|
|Also published as||US20080021461|
|Publication number||11491724, 491724, US 7967847 B2, US 7967847B2, US-B2-7967847, US7967847 B2, US7967847B2|
|Inventors||Boyd Thomas Barker, Jr., Eric Steven Heinz|
|Original Assignee||Warsaw Orthopedic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (15), Referenced by (3), Classifications (17), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Normal intervertebral discs between endplates of adjacent vertebrae distribute forces between the vertebrae and cushion vertebral bodies. The spinal discs and/or vertebral bodies along the spinal column may be displaced or damaged due to trauma, disease or aging. As a result, stabilization systems may be implanted along the spinal column to distribute loading from the spinal column between intact spinal structures. Such systems have employed rods positioned along two or more vertebrae and secured to the pedicles of the vertebrae with screws or hooks.
In the sacral region, rigid stabilization and reconstruction systems have been employed that include elongate members with a rod portion extending along the lumbar vertebrae and a plate portion secured to the sacral vertebrae or to the ilium. In view of the spinal column loading being supported by the rigid construct, such systems can also employ a separate fusion construct between the iliac wings to fuse the sacral region. Other stabilization systems and techniques along other portions of the spinal column also can involve implants in the disc space in combination with rods or plates extending along the vertebrae. The mass and various numerous separate components in such procedures can increase the potential for complications associated with such procedures, both during surgery and post-operatively.
The present invention is directed to spinal fusion rods and systems and methods for employing the same in spinal stabilization and reconstructions procedures. The spinal fusion rods can include a rod portion and a fusion portion extending from the rod portion along a longitudinal axis. The fusion portion can be formed by a cannulated, fenestrated body along the fusion rod. The fusion rods can be employed alone or in combination with other fusion rods in the stabilization and reconstruction systems. The rod portion can be attached to one or more vertebrae along the spinal column with the fusion portion engaging the ilium, sacrum or other pelvic structure. In other procedures, the rod portion is engaged to the pelvic region and the fusion portion engages an endplate of a vertebral body. Other systems are contemplated where the rod portion is engaged along one or more vertebrae and the fusion portion engages a vertebral endplate.
In one aspect, a fusion rod comprises a rod portion extending at least partially along a longitudinal axis from a first end to an intermediate portion. The fusion rod also includes a fusion portion extending at least partially along the longitudinal axis from the intermediate portion to a second end opposite the first end. The fusion portion includes a body defining a cavity and a number of wall openings about the body in communication with the cavity.
In another aspect, a fusion rod comprises an elongated solid rod portion extending along a longitudinal axis and a mesh cage-like structure extending from an end of the rod portion along the longitudinal axis.
In a further aspect, a spinal stabilization and reconstruction system comprise first and second fusion rods each including a rod portion extending along a longitudinal axis and a fusion portion extending from the rod portion along the longitudinal axis. Each of the fusion portions includes a cavity and a plurality of wall openings in communication with the cavity. The system further includes a plurality of anchors to secure the rod portions to at least one vertebra.
In still another aspect, a surgical method comprises: securing a rod portion of a fusion rod along a side of at least one lumbar vertebra; positioning a mesh portion of the fusion rod that extends from an end of the rod portion of the fusion rod in contact with a pelvic structure; and supporting spinal loads with the rod portion and the mesh structure while allowing bone growth into the mesh structure.
In yet another aspect, a surgical method comprises: securing a rod portion of a fusion rod with a pelvic structure; and positioning a fusion portion of the fusion rod in contact with an endplate of a lumbar vertebra. The fusion portion and the rod portion are engaged with one another along a central longitudinal axis.
These and other aspects are further discussed below.
For the purposes of promoting an understanding of the principles of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is intended thereby. Any alterations and further modification in the described processes, systems, or devices, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Spinal reconstruction and stabilization systems can be employed to reconstruct and stabilize portions of the spinal column, including the sacral region, to provide support of spinal column loads when spinal structures are no longer capable or effective to do so. The stabilization and reconstruction systems can include fusion rods having a rod portion and a fusion portion. The rod portion can be secured along portions of the spinal column or pelvic regions where due to anatomical constraints smaller or lower profile implants are desired. The fusion portion can be located along or adjacent to portions of the spinal column or pelvic region where fusion of adjacent bony structures to the fusion rod or to another is desired. The reconstruction systems can employ anchors to secure the fusion rod to bony tissue, and cross-connectors and other stabilization members to secure adjacent fusion rods to one another in side-by-side relation and also to adjacent bony structures. The reconstruction systems can employ fasteners to secure the rod portion and the fusion portion to the adjacent pelvic structure or vertebral bodies.
As shown in
Fusion portion 30 includes a body 32 extending from intermediate portion 20 to a second end 34. Body 32 can include a cross-section that is larger than that of rod portion 14. Body 32 can provide a mesh cage-like structure along fusion rod 10. Intermediate portion 20 can provide a gradual, tapering transition between the cross-sections. Intermediate portion 20 can be integrally formed with or joined to rod portion 14 and fusion portion 30. Other embodiments contemplate one or both of rod portion 14 and fusion portion 30 are removably joined with intermediate portion 20. Intermediate portion 20 can include a solid body to provide strength to the connection between rod portion 14 and fusion portion 30. Other embodiments contemplate intermediate portion 20 includes holes, cannulations, recesses, pits, apertures, or other structures.
Fusion portion 30 includes body 32 that is cannulated to define a lumen or cavity 40 extending from second end 34 to intermediate portion 20. Body 32 also includes a wall 36 extending around cavity 40 that includes a number of fenestrations or openings 38 extending through wall 36 and that are in communication with cavity 40. The openings 38 can form a mesh-like structure for wall 36 that provides strong load carrying capabilities with an open cell form to facilitate bone growth and incorporation of the fusion portion 30 with bony tissue. The openings can be triangular in shape as shown, or include any other shape, such as circular, oval, diamond, polygonal, non-circular, and random shapes. In addition, the opening shapes can be different from one another in the same fusion portion 30.
Body 32 can lie along longitudinal axis 12 in one plane as shown in
As shown in
Fusion portion 80 includes a body 82 extending from intermediate portion 70 to a second end 84. Body 82 can include a cross-section that is larger than that of rod portion 64. Body 82 can provide a mesh cage-like structure along fusion rod 60. Intermediate portion 70 can provide a gradual, tapering transition between the cross-sections. Intermediate portion 70 can be integrally formed with or joined to rod portion 64 and fusion portion 80. In the illustrated embodiment, intermediate portion 70 includes an axially oriented end opening 74 and rod portion 64 is positioned therein. Intermediate portion 70 includes a hole 76 in a side thereof to receive an engaging member such as a set screw or other fastener to couple rod portion 64 in intermediate portion 70.
The separability of rod portion 64 and fusion portion 80 allows the surgeon to select from rod portions and fusions portions of differing lengths, cross-sections, materials, or other properties to secure to one another based on the anatomical conditions or other treatment options that may be desired. In one embodiment, fusion portion 80 can be formed of resorbable material that resorbs over time to provide short-term stabilization, and rod portion 64 can be non-resorbable to provide long-term stabilization. In another embodiment, rod portion 64 can be formed of resorbable material that resorbs over time to provide short-term stabilization, and fusion portion 80 can be non-resorbable to provide long-term stabilization. In another embodiment, both the rod portion and the fusion portion are resorbable. In yet another embodiment, both the rod portion and the fusion portion are non-resorbable. Rod portion 64 can be made from a first material and fusion portion 80 can be made from a second material that differs from the first material. For example, rod portion 64 could be made from a metal or metal alloy such as titanium or stainless steel, and fusion portion 80 could be made from a polymer or poly-ether type material such as polyetheretherketone (PEEK). In another example, fusion portion 80 could be made from a metal or metal alloy such as titanium or stainless steel, and rod portion 64 could be made from a polymer or poly-ether type material such as PEEK.
As discussed further below, intermediate portion 70 includes receptacles 77, 78 to receive other components of a stabilization system. It should be understood, however, that fusion rod 60 can include an intermediate portion like that discussed above for fusion rod 10, and fusion rod 10 can include an intermediate portion like that discussed with respect to fusion rod 60.
Fusion portion 80 includes body 82 that is cannulated to define a lumen or cavity 90 extending from second end 84 to intermediate portion 70. Body 82 also includes a wall 86 extending around cavity 90 that includes a number of fenestrations or openings 88 extending through wall 86 and that are in communication with cavity 90. The openings can be of any shape and form a mesh-like structure for wall 86 that provides strong load carrying capabilities with an open cell form to facilitate bone growth and incorporation of the fusion portion 80 with bony tissue.
Body 82 can lie along longitudinal axis 62 in one plane as shown in
As shown in
Fusion portion 130 includes a body 132 extending from intermediate portion 120 to a second end 134. Body 132 can provide a mesh cage-like structure along fusion rod 110. Body 132 can include a cross-section that is larger than that of rod portion 114. Intermediate portion 120 can provide a gradual, tapering transition between the cross-sections. Intermediate portion 120 can be integrally formed with or joined to rod portion 114 and fusion portion 130. Intermediate portion 120 includes axially aligned receptacles 126, 127, 128 in respective sides thereof. An engaging member such as a set screw or other fastener can be positioned in one receptacle 126 while another component of the system extends through or into receptacles 127, 128. The engaging member in receptacle 126 can secure the transverse component to intermediate portion 120. It should be understood, however, that fusion rod 110 can include an intermediate portion like that discussed above for fusion rods 10 and 60, and fusion rods 10 and 60 can include an intermediate portion like that discussed with respect to fusion rod 110.
Fusion portion 130 includes body 132 that is cannulated to define a lumen or cavity 140 extending from second end 134 to intermediate portion 120. Body 132 also includes a wall 136 extending around cavity 140 that includes a number of fenestrations or openings 138 extending through wall 136 and that are in communication with cavity 140. The openings can be of any shape and form a mesh-like structure for wall 136 that provides strong load carrying capabilities with an open cell form to facilitate bone growth and incorporation of the fusion portion 130 with bony tissue.
Body 132 can lie along longitudinal axis 112 in one plane as shown in
Referring now to
In the illustrated embodiment, anchors 150, 152 can be identical and each can include a proximal U-shaped head 154 and a distal screw-like bone engaging portion to engage bony tissue of the vertebral body. The head can receive the rod portion therein, and an engaging member 156 in the form of a set screw as shown, or in the form of a cap or the like, can be engaged to the head to capture the rod portion therein. Other embodiments contemplate that the anchors are different from one another. Other forms for the anchors include hooks, staples, cables, wires, plates, intradiscal implants, and other spinal implant devices. The head portion can be pivotally coupled to the screw portion to provide a multi-axial or multi-positional arrangement therebetween so that the head can be re-oriented as desired. The head portion can also be fixed relative to the screw portion to provide a fixed, uni-axial arrangement therebetween.
With the respective rod portions 114 a, 114 b secured to vertebrae L4 and L5, fusion portion 130 a, 130 b extends caudally therefrom where ends 134 a, 134 b contact the respective ilium 212, 214 of the pelvic structure 210. The ends 134 a, 134 b distribute the spinal column loading over the respective ilium. Fusion portions 130 a, 130 b can include bone growth material packed or positioned therein to support bone growth for further mechanical stabilization of the reconstructed portion of the spine. Containment of the graft and bone growth material in the mesh structure of fusion portions 130 a, 130 b may increase the rate of the osteogenic process. To provide additional stability, the fusion portions 130 a, 130 b can be fastened or secured to the pelvic structure with one or more wires, sutures, cables, bone screws, staples, rods, connectors, or other securing device. The fasteners can extend through one or more of the wall openings of the mesh structure and engage the adjacent bony structure to secure the mesh portion thereto.
Transverse stabilization member 242 includes an elongated rod-like body 260 that extends between opposite ends 262, 264 contacting the ilia 212, 214, respectively. Body 260 extends through clamping assemblies 266, 268 engaged along the respective rod portions 64 a, 64 b between the ends of rod portions 64 a, 64 b and the bend forming the angular offset of rod portions 64 a, 64 b. Cross-link 184 is located between the fusion portions 80 a, 80 b and the respective bends forming the angular offset portion of the rod portions 64 a, 64 b.
The clamping assemblies 266, 268 can be identical to one another. Clamping assemblies 266, 268 include a C-shaped clamp member 270 positioned around the rod portion 64 a, 64 b and an eye-bolt 272 extending through an end of the clamp member 270 and defining a passage for receiving the transverse stabilization member 242 therethrough. When the eye-bolt is tightened, the C-shaped clamp member 270 clamps in position around the respective rod portion 64 a, 64 b and the transverse stabilization member 242 is clamped in the eyebolt passage.
The stabilization and reconstruction systems are shown in regard to sacral and lumbar vertebrae reconstruction systems. Such systems can be employed in other regions of the spine, and can also be employed with single fusion rods or with three or more fusion rods.
While the invention has been illustrated and described in detail in the drawings and the foregoing description, the same is considered to be illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are desired to be protected.
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|Cooperative Classification||A61F2210/0004, A61F2/44, A61F2002/30604, A61F2002/30235, A61F2220/0033, A61F2002/30784, A61F2002/30062, A61B17/7032, A61F2220/0025, A61B17/7055, A61F2230/0069, A61F2002/30507, A61F2002/30331|
|European Classification||A61F2/44, A61B17/70G|
|Jul 24, 2006||AS||Assignment|
Owner name: WARSAW ORTHOPEDIC INC., INDIANA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BARKER JR, BOYD THOMAS;HEINZ, ERIC STEVEN;REEL/FRAME:018130/0010;SIGNING DATES FROM 20060717 TO 20060719
|Dec 29, 2014||FPAY||Fee payment|
Year of fee payment: 4